VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002, United States
NCT Number: NCT07397182
Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Symptom Management and Rehabilitation Therapy (SleepSMART) was developed as an adapted form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for older Veterans with cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence. In a recent pilot investigation, SleepSMART was found to be feasible, acceptable, and demonstrated preliminary efficacy among a sample of Veterans with co-morbid insomnia and MCI. This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older Veterans with insomnia and MCI.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92161-0002, United States
With increasing age, adults report greater frequency of insomnia symptoms, including difficulty falling and staying asleep, waking too early, and associated impairments in daytime functioning and quality of life. Veterans are particularly vulnerable to insomnia, with rates double and even triple those of civilian populations. When left untreated, chronic insomnia may contribute to increased risk for cognitive decline (e.g., Alzheimer's disease) and can lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life. CBT-I is the first-line treatment for insomnia, but factors like poor adherence and poor recall for CBT-I content can diminish its impact for certain populations. Specifically, the cognitive impairments experienced by individuals with Mild Cognitive Impairment (MCI) may limit the adherence and rate of progress in CBT-I. Therefore, it is critical to ensure that vulnerable populations, such as older Veterans with MCI, can fully benefit from sleep treatment. The study team developed SleepSMART (Sleep Symptom Management and Rehabilitation Therapy) to help cognitively impaired Veterans learn and adhere to the CBT-I regimen, thereby leading to faster and more complete sleep treatment benefits. Based on the results of a recent pilot investigation, SleepSMART demonstrated preliminary efficacy as a modified form of CBT-I treatment that is uniquely tailored to aging Veterans with MCI. This investigation will build on previous research by conducting a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I, in 150 Veterans age 60+ with insomnia and MCI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This manualized approach to treatment involves 6 weekly sessions and addresses the underlying causes of insomnia utilizing sleep restriction and stimulus control techniques, relaxation training, and relapse prevention. In Session 1 sleep education, goal setting, and Sleep Restriction Therapy (SRT) guidelines will be introduced. In Session 2 the Veteran's sleep diary will be reviewed, time in bed (TIB) will be modified based on SRT, and Stimulus Control (SC) instructions will be provided. Session 3 will commence with a review of the sleep diary and adjustments to TIB will be made. In this session a discussion of cognitive factors that may impact insomnia and therapy adherence will be discussed. Additionally, stress management and/or relaxation training will be introduced. In Sessions 4 and 5 sleep diaries will be reviewed, adherence to the treatment discussed, and TIB will be modified based on SRT rules. In Session 6 continued care and relapse prevention plans will be developed.
This treatment involves six 50-minute sessions and addresses key CBT-I components including sleep education, sleep restriction/sleep compression therapy, stimulus control techniques, cognitive therapy, relaxation training, and relapse prevention. Each session includes CogSMART cognitive strategies designed to support treatment learning and adherence.
Time frame: Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)
Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20) scores on the ISI will be compared.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
Acronym: SleepSMART
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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